Cleared Traditional

K971134 - VISTA EYESHOWER

K971134 · John Branch · Anesthesiology device
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Nov 1997
Decision
221d
Days
-
Risk

K971134 is an FDA 510(k) clearance for the VISTA EYESHOWER. Classified as Cup, Eye (product code LXQ).

Submitted by John Branch (Irvine, US). The FDA issued a Cleared decision on November 4, 1997 after a review of 221 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K971134

510(k) Number K971134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1997
Decision Date November 04, 1997
Days to Decision 221 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 140d · This submission: 221d
Pathway characteristics
Predicate-based equivalence.

LXQ Device Classification - Class 0,

Product Code LXQ Cup, Eye
Device Class -